Potassium Titanyl Phosphate Laser Versus Pulsed Dye Laser for Rosacea - a Prospective Case-Control Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- reduction of erythema
研究概览
简要总结
To compare the efficacy and safety of 532 nm KTP and 585 nm PDL for treating rosacea.
详细描述
Rosacea is a common, chronic inflammatory skin disease that usually affects the cheeks, nose, forehead, and chin [1]. Clinically, it presents initially with transient erythema (flushing) and telangiectasia. As it progresses, persistent erythema and papules and pustules appear. Phymatous changes result from hypertrophy of the sebaceous glands, and usually manifest as rhinophyma, gnatophyma, and metophyma [2]. Depending on the literature, rosacea has a prevalence of 1% to 22% [3]. Time of manifestation of the disease is usually between 30 and 50 years [4]. Women are more frequently affected [4].
For laser treatment of rosacea, the pulsed dye laser (PDL) with a wavelength of 595nm is frequently used. The treatment includes at least three sessions at intervals of about 4 weeks and leads to lightening and reduction of the lesions as well as reduction of papules and pustules. Various clinical studies have already demonstrated the high efficacy of PDL [5-7]. The treatment is painless, and local or general anesthesia is not necessary.
The KTP laser is also an option in the treatment of rosacea. Due to the more stable technology of the frequency-doubled Nd:YAG (KTP) and associated lower maintenance problems, this laser system appears to be a safer and more reliable treatment option for rosacea patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women 18 years and older
- •Good general health, no relevant previous diseases
- •Presence of rosacea
- •Cognitive ability and willingness to give consent (Informed Consent)
排除标准
- •Age < 18 years
- •Pregnant and breastfeeding women
- •Significant open wounds or lesions of the region to be treated
- •Metallic implants in the region to be treated
- •Missing consent and/or data protection declarations
结局指标
主要结局
reduction of erythema
时间窗: at follow-up visit 4 weeks after last treatment session
assessment scale 0 - 4 (normal skin - severe erythema) evaluated by physician and blinded investigator
pain intensity
时间窗: at follow-up visit 4 weeks after last treatment session
using numeric rating scale 0 - 10 (none - unbearable pain) evaluated by subjects
swelling
时间窗: at follow-up visit 4 weeks after last treatment session
assessment scale 1 - 6 (very - none) evaluated by subjects
purpura
时间窗: at follow-up visit 4 weeks after last treatment session
assessment scale 1 - 6 (very - none) evaluated by subjects
次要结局
- patient satisfaction(at follow-up visit 4 weeks after last treatment session)
